Clinical Trials /

Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC

NCT02913196

Description:

This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate,
docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer
(mCRPC).
This study is designed to determine the dose that apalutamide can be administered safely in
combination with abiraterone acetate, docetaxel and prednisone.

Phase:

URL:

Trial Eligibility

Document

Title

Official Title: A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Clinical Trial IDs

ORG STUDY ID:
1509016578

NCT ID:
NCT02913196

Conditions

Prostate Cancer Metastatic

Interventions

Drug

Synonyms

Arms

Apalutamide

ARN-509

All patients

Abiraterone acetate

Zytiga

All patients

Docetaxel

Taxotere

All patients

Prednisone

Deltasone

All patients

Purpose

This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate,
docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer
(mCRPC).
This study is designed to determine the dose that apalutamide can be administered safely in
combination with abiraterone acetate, docetaxel and prednisone.

Detailed Description

Subjects are enrolled in up to three 3-6-subject cohorts and are administered combination
(apalutamide, abiraterone acetate and docetaxel plus prednisone) according to a
dose-escalation schedule. The first dose of docetaxel infusion begins on Day 1 Cycle 1. Daily
oral apalutamide, abiraterone acetate plus twice-daily oral prednisone begins on Day 1 Cycle
1. Docetaxel 1-hour infusions are administered intravenously every 3 weeks (Q3W), preceded by
oral dexamethasone. While a subject is receiving chemotherapy, a treatment cycle is defined
as 21 days. Dose limiting toxicity (DLT) determination is based on toxicities observed within
the initial 2 cycles defined as 6 weeks. DLT will be assessed before the start of the third
docetaxel infusion. Once a combination dose is determined to be safe (i.e. no more than 2 of
6 subjects experience DLT), the next cohort will enroll. Subjects remain at their allocated
combination dose until the maximum tolerated dose (MTD) is determined.
The primary objective is to determine a safe dose combination of apalutamide plus abiraterone
acetate, docetaxel, prednisone in subjects with mCRPC.